Label: PHAZYME- simethicone capsule, gelatin coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated March 16, 2016

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  • Active Ingredient

    (in each softgel)

    Simethicone 180mg

  • Purpose

    Anti-gas

  • Use

    relieves bloating, pressure or fullness commonly referred to as gas

  • Warnings

  • Stop use and ask a doctor if

    condition persists

  • Keep out of reach of children.

  • Directions

    • swallow one or two softgels after a meal
    • do not exceed two softgels per day except under the advice and supervision of a physician
  • Other Information

    store at room temperature 59º - 86ºF (15º - 30ºC)

  • Inactive Ingredients

    FD&C Yellow No. 6, Gelatin, Glycerin, White Edible Ink

  • Questions?

    Call toll-free 1-855-727-4277

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    PHAZYME 
    simethicone capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0210
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColororangeScoreno score
    ShapecapsuleSize11mm
    FlavorImprint Code PZ;180
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0210-2424 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    export only01/01/1998
    Labeler - C.B. Fleet Company, Inc. (003119054)
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